Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00918554
• Date of registration: 09/06/2009
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis UVEXATE
• Scientific title: Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE
• Date of first enrolment: September 2009
• Target sample size: 7
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00918554
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Sébastien ABAD, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients over 18 years old

- Provided written consent for participation in the trial prior to any study-specific
procedures or requirements

- Posterior uveitis or panuveitis associated with macular oedema defined as increased
macular thickness (more than 250 mm assessed by Stratus TD-OCT or 300 mm with Cirrus
SD-OCT ) and/or the presence of cystoid spaces in the macula, and the absence of
epiretinal membranes.

- Patient with oral contraception

- Posterior uveitis or panuveitis associated with macular oedema

- Patients with histologically proven sarcoidosis or a presumed sarcoidosis. In case of
a non caseating granuloma in biopsy tissues, the patients with presumed sarcoidosis
meet at least 2 of the 4 following criteria: typical changes on chest radiography and
computed tomography; predominantly CD4 lymphocytosis in bronchoalveolar lavage (BAL)
fluid; elevated serum ACE levels; elevated gallium or 5 fluorodeoxyglucose uptake

Exclusion Criteria:

- Patients who do not fulfill the inclusion criteria

- Other causes of uveitis

- Extra ophthalmologic manifestations of sarcoidosis justifying corticosteroids

- Patients previously treated with immunosuppressive agents or corticosteroids of more
than 10 mg daily over 15 days.

- Patients with life-threatening conditions

- Chronic hepatopathy or renal failure

- Uncontrolled diabetes mellitus



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcoid-associated Uveitis

Ocular Sarcoidosis

Macular Edema

Intervention(s)

Drug: Methotrexate

Drug: Placebo

Primary Outcome(s)

Percentage of macular oedema relapses. Every two weeks for five months, the amount of macular oedema will be assessed by Optical Coherence Tomography. [Time Frame: at 26 weeks]

Secondary Outcome(s)

Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0. [Time Frame: at 26 weeks]

Adverse effects [Time Frame: at 26 weeks]

Cumulated dose of prednisone [Time Frame: at 26 weeks]

Number of triamcinolone injections [Time Frame: at 26 weeks]

Percentage of patients with active anterior and /or posterior uveitis [Time Frame: at 26 weeks]

Secondary ID(s)

P070140

Source(s) of Monetary Support

Please refer to primary and secondary sponsors